High blood pressure drug that reportedly had tainted clinical studies causes skin problems. Researchers with a government-affiliated agency say 41 people who took the drug, Diovan, have complained of swelling or itching. Diovan has been sold in Japanese pharmacies since 2000 and about 4 million people are taking it.
The researchers conducted a further study and concluded they cannot rule out the possibility that Diovan was the cause of the problems in 18 cases. Ministry officials reportedly ordered the Tokyo unit of the Swiss-based company on Tuesday to include the risks in usage descriptions.
The drug is used in about 100 countries since it was first approved in Germany 17 years ago.
Diovan is also at the center of another investigation in Japan as clinical studies on the drug seem to have been manipulated by the first company that tested the product in Japan. The drug is produced by the global pharmaceutical company, Novartis Pharma.
JikeiUniversity, a medical school in Tokyo, announced earlier this month the preliminary results of a probe into a study by its researchers on the effects of Diovan.
According to the panel of experts their results do not match the preliminary chart, filled after the first set of tests. The panel believes the data was not altered by the school’s researchers. It says the analysis was carried out by a former official of Novartis Pharma, the media writes. Also, another problem with the paperwork of this drug is that the researchers falsely reported that the pharmaceutical company did not participate in the study.
The former company official is said to have been involved in clinical tests of Diovan at a number of medical schools. Earlier this month, Kyoto Prefectural University of Medicine said its clinical study may have wrongly concluded that the drug is more effective than other medications in reducing brain strokes and angina.
Novartis Pharma used the results of the clinical study to promote Diovan that has annual sales of about $ 1 billion.